Clinical Trial Manager, FSP

• Manage clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP
• Assume Clinical Study Manager responsibilities on small or less complex projects when required
• Develop clinical tools, monitoring plans, monitoring guidelines, and contribute to the Data Quality Plan and Master Action Plan
• Ensure timely setup, organization, content, and quality of relevant Trial Master File sections
• Participate in designing CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents
• Collaborate with project managers to prepare and present at client, bid defense, and hand-off meetings
• Collaborate with clinical and cross-functional teams, lead team meetings, and maintain timelines, resources, interactions, and quality
• Implement and train teams on standardized clinical monitoring processes
• Archive study documents and materials in a timely manner
• Prepare and monitor clinical activity timelines and metrics, provide status updates, review projects, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution
• Monitor or co-monitor clinical trials to assess performance and meet contractual obligations
• Conduct Accompanied Field Visits and manage project financials in smaller regions when required
• Communicate with study sites regarding protocol, patient participation, case report forms, and study-related issues
• Coordinate study start-up activities and ensure timely ethics committee and regulatory submissions
• Ensure essential document quality meets Regulatory Compliance Review expectations and follow up on ethics committee questions
• Provide input into clinical activity forecasts
• Manage clinical resources, assign and delegate responsibilities, and identify additional resource requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification
• 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job
• Equivalent combination of appropriate education, training, and/or directly related experience may be considered
• English language proficiency
• Familiarity with clinical monitoring practices, processes, and requirements
• Understanding of relevant regulations, including ICH/GCP and FDA guidelines
• Good computer skills, including Outlook, Excel, Word, and automated systems
• Leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, and decision-making skills
• Ability to work effectively in a changing environment with complex or ambiguous situations
• Ability to evaluate workload against project budget and adjust resources accordingly
• Knowledge of budgeting, forecasting, and fiscal management
• Strong attention to detail
• Willingness and ability to frequently drive to site locations and travel domestically and internationally

• Fully remote work mode
• Standard Monday–Friday work schedule
• Collaboration and professional development opportunities
• Mentoring and training environment
• Global team environment
• Exposure to scientific innovation and excellence